Bayer HealthCare Pharmaceuticals Inc. announced today that the U.S. Food and Drug Administration has approved Gadavist (gadobutrol) Injection, a macrocyclic gadolinium-based contrast agent (GBCA), for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system (CNS).

Gadavist is formulated at a higher concentration (1 mmol/mL) compared to certain other GBCAs. Compared to 0.5 molar gadolinium-based contrast agents, the higher concentration of Gadavist results in half the volume of administration and a more compact contrast bolus. It is important to closely examine the dosing table in the full prescribing information to determine the volume of Gadavist to be administered.

"The approval of Gadavist enriches our strong portfolio of MRI contrast media and provides a new option for U.S. healthcare providers in contrast-enhanced imaging of the CNS," said John Rotondo, Vice President, Commercial Operations, Bayer HealthCare Pharmaceuticals. "Our MR contrast agents are some of the most widely used today, and Bayer is proud to be a world leader in diagnostic imaging."

IMPORTANT SAFETY INFORMATION

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.

The risk for NSF appears highest among patients with:

Chronic, severe kidney disease (GFR < 30 mL/min/1.73m(squared)), or

Acute kidney injury.

Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.

For patients at highest risk for NSF, do not exceed the recommended Gadavist dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions].

The possibility of serious or life-threatening hypersensitivity, anaphylactic or anaphylactoid reactions associated with cardiovascular, respiratory, or cutaneous manifestations, including death, should always be considered.

The most frequent adverse reactions associated with Gadavist in clinical studies were headache, nausea, injection site reaction, dysgeusia and feeling hot.